Table 1.

Criteria list for methodological quality assessment of selected phase II studies of biological therapies of solid tumors

Study population  A. Patient selection   Zero points if patients are not selected on a validated biological/molecular basis; 10 points if they are  B. Trial size   2 points if total number of patients is <30; 6 points if >30 or <50; 10 points if >50

Analysis and measurement of biological effect  C. Study design   Zero points if not reported; 10 points if yes  D. Biological endpoints   Zero points if not reported; 10 points if evaluations of biological endpoints are planned

Modality of response and toxicity reporting  E. Response   Zero points if criteria for response assessment are not reported; 10 points if yes  F. Toxicity   Zero points if criteria for toxicity evaluation are not reported; 10 points if yes

Modality of preclinical evidence and data reporting  G. PERI   Zero points if preclinical evidence is not cited; 2 points if PEI<15; 8 points if PEI>15  H. Sites of disease   Zero points if not reported; 8 points if reported  I. Compliance with treatment   Zero points if not reported; 8 points if reported  J. Time-to-event descriptions   Eight points if overall-survival and/or disease-free survival are reported  K. Follow-up   Eight points if any information about follow-up is reported (duration, lost to follow-up)